Dietary Treatment of Infants With Chylothorax

The Effectiveness of Low Fat Breast Milk for the Treatment of Chylothorax in Infants Following Cardiothoracic Surgery: A Pilot Study

Chylothorax occurs in ~3 to 5 % of infants undergoing cardiac surgery. Standard treatment requires discontinuation of breast milk feeding, due to the abundance of long chain triglycerides, and transition to a medium chain triglyceride (MCT) based formula. Objective: To determine the effectiveness of fat-modified breast milk (MBM) for the treatment of chylothorax compared with MCT-formula. Hypothesis: The investigators primary hypothesis was that infants fed MBM would have more chyle drainage in the first 5 days after diagnosis compared to infants fed an MCT based formula which is the current standard of care. Design: Infants with chylothorax were eligible. Treatment infants (n=8) received mother's own milk that had been modified by removing the fat layer via centrifugation and adding MCT and nutrients to provide 67 kcal/mL and 11 g/100 mL protein (MBM group). Control infants (n=8) received an MCT-formula (MCT group). The feeding intervention was a minimum of 6 weeks after chest tube removal per The Hospital for Sick Children standard chylothorax treatment protocol. Outcome measures collected included chyle drainage from chest tubes, weight, length and head circumference measurements and estimated energy and nutrient intake.

Study Overview

• Status: Completed
• Conditions: Chylothorax
• Intervention / Treatment: Other: Fat-Modified Breast Milk; Other: MCT formula

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Infants < 12 months of age who were diagnosed with chylothorax.
• Infants included in the intervention group (MBM) needed to have received >80% of their enteral feeds as breast milk prior to surgery.
• Infants included in the control group (MCT-formula) needed to have received <80% of their enteral feeds as breast milk prior to surgery.

Exclusion Criteria:

• Subjects were excluded if their diagnosis made it unlikely that they would be able to follow the hospital's standard 6 week protocol for treatment of chylothorax
• Were receiving only parenteral nutrition at the time of diagnosis of chylothorax
• Primary caregiver of the baby did not have good comprehension of English.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fat-Modified Breast Milk; Infants in this arm of the study were fed their own mother's breast milk where the fat layer was removed by centrifugation. Prior to feeding, extra energy and nutrients were added to the defatted breast milk.	Other: Fat-Modified Breast Milk
Active Comparator: MCT-formula group; Infants in this arm of the study were fed a MCT-containing medical food which is the current standard of care.	Other: MCT formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chyle Drainage from Chest Tubes	This outcome includes measurement of chyle drainage from chest tubes in the first 5 days after diagnosis of chylothorax and the number of days of chest tube drainage.	6 weeks of chylothorax treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Growth	Infant weight, length and head circumference measurements were determined at study initiation and at the first post-discharge follow-up visit (within one-week of discharge) and again at the end of chylothorax treatment.	6 weeks of the chylothorax treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated Nutrient Intakes	Average daily energy, protein and other nutrient intakes were calculated using milk volumes consumed (recorded in the medical record [in-hospital] or 3 day consecutive food records [after discharge]), analyzed breast milk fat composition values, milk nutrient values from the literature, product monographs and Food Processor SQL Ed v. 10.2 (ESHA Research).	6 weeks of chylothorax treatment

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Collaborators: Labatt Family Heart Centre; Trainee award through Ontario Student Opportunity Trust Fund - The Hospital for Sick Children Foundation Scholarship
• Investigators: Principal Investigator: Deborah L O'Connor, PhD RD, The Hospital for Sick Children; Principal Investigator: Sarah Kocel, MSc RD, The Hospital for Sick Children; Principal Investigator: Jennifer Russell, MD, The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: May 12, 2014
• First Submitted That Met QC Criteria: May 17, 2014
• First Posted (Estimate): May 21, 2014

Study Record Updates

• Last Update Posted (Estimate): May 21, 2014
• Last Update Submitted That Met QC Criteria: May 17, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: cardiac surgery; infants; breast milk; chylothorax; modified breast milk
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Chylothorax
• Other Study ID Numbers: 1000011037; 1000037303 (Other Identifier: The Hospital for Sick Children Research Ethics Board)